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Trial record 1 of 1 for:    GRC17
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Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®

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ClinicalTrials.gov Identifier: NCT00836953
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : August 27, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza virus vaccine (Pediatric formulation)
Enrollment 33
Recruitment Details The study participants were enrolled from 11 through 25 September 2003 in 1 US site.
Pre-assignment Details A total of 33 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Study Group
Hide Arm/Group Description Participants received study vaccine on Days 0 and 30.
Period Title: Overall Study
Started 33
Completed 31
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             1
Arm/Group Title Study Group
Hide Arm/Group Description Participants received study vaccine on Days 0 and 30.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
33
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Age Continuous Number Analyzed 33 participants
19.08  (9.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
16
  48.5%
Male
17
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination
Hide Description Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
Time Frame Day 0 to 3 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received study vaccine on Days 0 and 30.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Participants
Any Solicited Local Reaction Post-Dose 1 9
Any Redness (> 5 mm) 6
Grade 3 Redness (> 50 mm) 0
Any Induration (> 5 mm) 2
Grade 3 Induration (> 50 mm) 0
Any Bruising (> 5 mm) 3
Grade 3 Bruising (> 50 mm) 0
Any Pain 7
Grade 3 Pain (Cries when leg or arm is moved) 0
Any Solicited Local Reaction Post-Dose 2 12
Any Redness (> 5 mm) 6
Grade 3 Redness (> 50 mm) 0
Any Induration (> 5 mm) 5
Grade 3 Induration (> 50 mm) 0
Any Bruising (> 5 mm) 2
Grade 3 Bruising (> 50 mm) 0
Any Pain 9
Grade 3 Pain (Cries when leg or arm is moved) 0
Any Solicited Local Reaction Post-Any Dose 14
Any Redness (> 5 mm) 8
Grade 3 Redness (> 50 mm) 0
Any Induration (> 5 mm) 5
Grade 3 Induration (> 50 mm) 0
Any Bruising (> 5 mm) 5
Grade 3 Bruising (> 50 mm) 0
Any Pain 10
Grade 3 Pain (Cries when leg or arm is moved) 0
Any Solicited Systemic Reaction Post-Dose 1 19
Fever (Rectal Temp) 6
Grade 3 Fever (> 103.1 ºF) 2
Any Irritability 10
Grade 3 Irritability (> 3 hours) 2
Any Crying 11
Grade 3 Crying (inconsolable for > 3 hours) 1
Any Lethargy 9
Grade 3 Lethargy (Uninterested in usual activity) 0
Any Appetite Decreased 11
Grade 3 Appetite Decreased (Refuses ≥ 3 feeds) 1
Any Vomiting 3
Grade 3 Vomiting ( ≥ 3 episodes) 1
Any Diarrhea 6
Grade 3 Diarrhea ( > 5 diarrhea stools/day) 0
Rash - Presence of Welts 0
Any Solicited Systemic Reaction Post-Dose 2 14
Fever (Rectal Temp) 2
Grade 3 Fever (> 103.1 ºF) 0
Any Irritability 12
Grade 3 Irritability (> 3 hours) 0
Any Crying 7
Grade 3 Crying (inconsolable for > 3 hours) 0
Any Lethargy 7
Grade 3 Lethargy (Uninterested in usual activity) 0
Any Appetite Decreased 8
Grade 3 Appetite Decreased (Refuses ≥ 3 feeds) 0
Any Vomiting 3
Grade 3 Vomiting ( ≥ 3 episodes) 0
Any Diarrhea 4
Grade 3 Diarrhea (> 5 diarrhea stools/day) 0
Rash - Presence of Welts 1
Any Solicited Systemic Reaction Post-Any Dose 22
Any Fever 7
Grade 3 Fever (> 103.1 ºF) 2
Any Irritability 15
Grade 3 Irritability (> 3 hours) 2
Any Crying 12
Grade 3 Crying (inconsolable for > 3 hours) 1
Any Lethargy 11
Grade 3 Lethargy (Uninterested in usual activity) 0
Any Appetite Decreased 14
Grade 3 Appetite Decreased (Refuses ≥ 3 feeds) 1
Any Vomiting 4
Grade 3 Vomiting (≥ 3 episodes) 1
Any Diarrhea 7
Grade 3 Diarrhea (> 5 diarrhea stools/day) 0
Rash - Presence of Welts 1
2.Other Pre-specified Outcome
Title Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)
Hide Description Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.
Time Frame Day 0 and Day 14 after Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received study vaccine on Days 0 and 30.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Percentage of Participants
A/Panama (H3N2) Pre-vaccination 10
A/Panama (H3N2) Post-dose 2 77
A/New Caledonia (H1N1) Pre-vaccination 10
A/New Caledonia (H1N1) Post-dose 2 81
B/Hong Kong Pre-vaccination 0
B/Hong Kong Post-dose 2 48
3.Other Pre-specified Outcome
Title Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)
Hide Description Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.
Time Frame Day 0 and Day 14 Post-dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.
Arm/Group Title Study Group
Hide Arm/Group Description:
Participants received study vaccine on Days 0 and 30.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Percentage of Participants
A/Panama (H3N2) 84
A/New Caledonia (H1N1) 94
B/Hong Kong 81
Time Frame Adverse events were collected for the entire study period, from the day of vaccination to Day 44 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group
Hide Arm/Group Description Participants received study vaccine on Days 0 and 30.
All-Cause Mortality
Study Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group
Affected / at Risk (%) # Events
Total   0/33 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Group
Affected / at Risk (%) # Events
Total   19/33 (57.58%)    
Gastrointestinal disorders   
Constipation * 1  2/33 (6.06%)  2
Teething * 1  2/33 (6.06%)  2
Vomiting NOS * 1  4/33 (12.12%)  4
General disorders   
Pyrexia * 1  5/33 (15.15%)  5
Infections and infestations   
Nasopharyngitis * 1  9/33 (27.27%)  9
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/33 (9.09%)  3
Nasal congestion * 1  3/33 (9.09%)  3
Rhinorrhoea * 1  7/33 (21.21%)  7
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00836953     History of Changes
Other Study ID Numbers: GRC17
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: July 20, 2009
Results First Posted: August 27, 2009
Last Update Posted: April 14, 2016